Effect of Inspiratory Muscle Training (IMT) on Breathing, Balance, and Blood Pressure Maintenance in Spinal Cord Injury (SCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Sustained Maximal Inspiratory Pressure (SMIP)
研究概览
简要总结
The purpose of this study is to help understand how training breathing muscles will impact balance, blood pressure, and quality of life of participants with spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Upper/lower/both extremity weakness or paralysis resulting from SCI with ASIA Impairment Scale (AIS) grades A-C who use a wheelchair as primary means of mobility.
- •≥1 year post-injury
- •Willingness to participate in the study and provide consent.
排除标准
- •Inability to understand the consent form or consent process
- •Reliance on a mechanical ventilator.
- •Use of Betablockers
- •Inability to travel to The Miami Project for weekly sessions during intervention month
- •Any complication that would limit transfer ability, or compromise supine or sitting tolerance, including but not limited to:
- •Fracture, dislocation, or malformations affecting supine or sitting tolerance.
- •Spinal instability.
- •Pressure ulcers or skin integrity issues on contact surfaces that would prohibit sitting or lying in supine.
- •Individuals who are able to stand independently or with a walker
- •Unresolved deep vein thrombosis (DVT).
- •Hospitalization due to autonomic dysreflexia in the last 3 months.
- •Pregnancy determined by urine testing in sexually active females.
结局指标
主要结局
Sustained Maximal Inspiratory Pressure (SMIP)
时间窗: Week 12
SMIP measured in pressure-time units (PTU) will be assessed using the Pro2 handheld inspiratory measurement and training device connected to a tablet, phone or desktop.
Root Mean Squared of Successive Differences between Normal Heartbeats (rMSSD)
时间窗: Week 12
rMSSD, measured in milliseconds, will be derived from signals obtained by a Polar monitor (with elastic chest strap sensor) and analyzed using Kubios Heart Rate Variability (HRV) Analysis Software.
Functional Seated Balance
时间窗: Week 12
Functional Seated Balance will be measured using the Function in Sitting Test for SCI (FIST-SCI). FIST-SCI consist of 14 different standardized seated balance tasks and scored on a 5-point ordinal scale from 0-4. A higher score indicates increased independence.
Quality of Life (QoL)
时间窗: Week 12
QoL will be measured using the Quality of Life Index, SCI version (QOLI-SCI). QOLI-SCI is a set of two 37-items questionnaire with total scores ranging from 74 to 444 with the higher score indicating increased quality of life.
Independence
时间窗: Week 12
Independence will be measured using the Spinal Cord Independence Measured (SCIM). SCIM has a total score ranging from 0-100 with the higher score indicating increased independence.
Percent Compliance of Training Sessions
时间窗: 4 weeks
Feasibility of the IMT protocol will be reported as the percentage of completed daily sessions out of the 28 total session days.
Percent Compliance of Training Minutes
时间窗: 4 weeks
Feasibility of the IMT protocol will also be reported as the percentage of completed total time out of the 840 minutes total expected session minutes(30 minutes daily for 28 days).
Maximal Inspiratory Pressure (MIP)
时间窗: Week 12
MIP measured in cm H2O will be assessed using the Pro2 handheld inspiratory measurement and training device connected to a tablet, phone or desktop
Standard deviation of normal R-R intervals (SDNN)
时间窗: Week 12
SDNN, measured in milliseconds, will be derived from signals obtained by a Polar monitor (with elastic chest strap sensor) and analyzed using Kubios Heart Rate Variability (HRV) Analysis Software.
Systolic Blood Pressure (SBP)
时间窗: Week 12
Brachial systolic BP, evaluated in mmHg, will be evaluated using the contralateral arm with a Spot Vitals Monitor.
次要结局
- Maximal Expiratory Pressure (MEP)(Week 12)
- Inspiratory Duration (ID)(Week 12)
- Forced Vital Capacity(Week 12)
- Forced Expiratory Volume in one Second (FEV1)(Week 12)
- Peak Expiratory Flow (PEF)(Week 12)
- Heart Rate Variability (HRV) Frequency(Week 12)
- Diastolic Blood Pressure (DBP)(Week 12)
研究者
Lawrence Cahalin
Clinical Professor
University of Miami